Cancer Clinical Research Coordinator 2 - Early Drug Development
Cancer Clinical Research Coordinator 2 - Early Drug Development🔍School of Medicine, Stanford, California, United States📁Research📅Jun 08, 2021 Post Date📅89891 Requisition #Stanford University is seeking a Cancer Clinical Research Coordinator 2 in the Early Drug Development Group to conduct clinical research and work independently on complex clinical research studies. Independently manage significant and key aspects of a large study or all aspects of a few smaller research studies.Duties include:
- Oversee and manage subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract and analyze data.Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.Formally mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
- Strong interpersonal skillsProficiency with Microsoft Office and database applications.Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.Knowledge of medical terminology.
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.May require extended or unusual work hours based on research requirements and business needs.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Grade: H
- Department URL: http://cancer.stanford.edu/
- Requisition ID: 89891